Glycine, N-[5-(acetylamino)-4-[2-(2-bromo-4,6-dinitrophenyl)diazenyl]-2-methoxyphenyl]-N-(2-methoxy-2-oxoethyl)-, methyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 13. to 28. July 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline; coherence between data, results and conclusions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Blue ANT

IUPAC Name:

Disperse Blue ANT

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Disperse Blue ANT

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River France Laboratories, Domaine des Oncins B.P. 0109, F 69592 L’Arbresle Cedex, France
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: approximately 5 kg
- Housing: 1 per cage (during the study)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C+/-2 °C
- Humidity (%): 55%+/-15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): daily light/dark cycle of 12/12 hours

IN-LIFE DATES: From: 13. to 28. July 2015

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated (left) eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

Only once. Exposure for 1 hour.
No rinsing of the treated eye was performed after dosing.

Observation period (in vivo):

1, 24, 48, 72 hours; 7 and 14 days after dosing.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 1 hour
No rinsing of the treated eye was performed after dosing.

SCORING SYSTEM: Irritation to the cornea, iris and conjunctivae were assigned a numerical value according to the Draize scale.

TOOL USED TO ASSESS SCORE: macroscopic observation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

>= 1.7 - <= 2

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

>= 1 - <= 1.3

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight redness (score of 1), well defined chemosis (score of 2) and moderate discharge of the conjunctivae (score of 2) were recorded in all treated animals at the 1 hour post-dose observation. Twenty-four hours after dosing, all animals showed moderate redness, chemosis and discharge (score of 2). Moderate conjunctival redness (score of 2) was observed in all animals at the 48 hour observation. At this examination, slight discharge (score of 1) was noted in two animals (nos. 295 and 303), while moderate discharge (score of 2) was still noted in the remaining animal (no. 305). In addition, slight conjunctival chemosis (score of 1) was noted in two animals (nos. 303 and 305) but well defined chemosis (score of 2) was noted in one animal (no. 295). No conjunctival discharge or chemosis was seen in any animal from 72 hours after dosing onwards. At this examination, redness of the conjunctivae with slight grade (score of 1) was seen in two out of three animals (nos. 295 and 305) and moderate grade (score of 2) in one animal (no. 303). Seven days after treatment (Day 8), one animal only (no. 303) showed slight conjunctival redness (score of 1) while no ocular irritation was noted in the remaining treated animals. Recovery occurred in the remaining animal 14 days after treatment (Day 15). No irritation of the cornea or iris was seen during the whole observation period.

Other effects:

A blue staining of the conjunctivae, due to the colour of the substance, was noted in one animal (no. 295) up to 24 hours after treatment and up to 48 hours in two animals (nos. 303 and 305). Blue staining of the fur around the treated eye, due to the colour of the test item, was noted in all animals up to 48 hours after dosing. No signs of pain or distress were observed during the study. There was no indication of a systemic effect.
No relevant changes in body weight were seen during the course of the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A moderate reaction was observed following ocular administration of Disperse Blue ANT (Br) to the rabbit. However, the observed reaction was not sufficient in severity and incidence to require classification. In addition, it was completely reversible over a 14-day observation period in all animals.

Executive summary:

The acute ocular irritation of Disperse Blue ANT (Br) was investigated in rabbits.

A 0.1 g aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48 and 72 hours, 7 and 14 days after dosing.

Slight redness, well-defined chemosis and moderate discharge of the conjunctivae were recorded in all treated animals at the 1 hour post-dose observation. Twenty-four hours after dosing, all animals showed moderate redness, chemosis and discharge. Moderate conjunctival redness was observed in all animals at the 48 hour observation. Slight discharge was noted in two animals, while moderate discharge was still noted in the remaining animal. In addition, slight conjunctival chemosis was noted in two animals and well-defined chemosis was noted in one animal. No conjunctival discharge or chemosis was seen in any animal from 72 hours after dosing onwards. At this examination, redness of the conjunctivae was seen with slight grade in two out of three animals and with moderate grade in one animal. Seven days after treatment (Day 8), one animal showed slight conjunctival redness while no ocular irritation was noted in the remaining treated animals. Recovery occurred in the remaining animal 14 days after treatment (Day 15). No irritation of the cornea or iris was seen during the whole observation period.

A blue staining of the conjunctivae, due to the colour of the substance, was noted in one animal up to 24 hours after treatment and in two animals up to 48 hours after treatment.

There were no signs of pain/distress after dosing.

Changes in body weight were not remarkable.

There was no indication of a systemic effect related to treatment. A moderate reaction was observed following ocular administration of Disperse Blue ANT (Br) to the rabbit. However, the observed reaction was not sufficient in severity and incidence to require classification. In addition, it was completely reversible over a 14-day observation period in all animals.

These results indicate that the test item, Disperse Blue ANT (Br), has no significant effect on the eye of the rabbit. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would suggest the following:

 

Classification:         No category

Signal word:           No signal word required

Hazard statement:   No hazard statement required